Institutional Review Board

Objective

The IRB of the International Vaccine Institute is an appropriately constituted administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities. The IRB has the authority to approve, require modifications in, or disapprove all research activities involving humans.

The IVI IRB is operated in accordance with the Declaration of Helsinki, International Conferences on Harmonization Good Clinical Practice (ICH GCP), Council for International Organization of Medical Sciences (CIOMS), International Ethical Guidelines for Epidemiological Studies (2009), the World Health Organization (WHO) Operating Guidelines for Ethical Review Committee that Review Biomedical Research and local Good Clinical Practice.

IVI IRB Members

Name Role in IVI IRB Job Title Affiliation
Prof. Suk-Koo Lee IRB Chairperson (Non Affiliated) Professor, Department of Surgery Samsung Medical Center
Prof. Young-Mo Koo IRB Member (Non Affiliated) Assistant Professor, Department of Medical Humanities & Social Sciences University of Ulsan College of Medicine
Dr. Sushant Sahastrabuddhe IRB Member Program Director, Typhoid IVI
Ms. Deborah Hong IRB Member (Non Scientific) Head of the Development & Communications IVI
Dr. Soon Ae Kim IRB Member (Non Affiliated) Public Health Doctor N/A
Dr. Yae-Jean Kim IRB Member (Non Affiliated) Associate Professor,Department of Pediatrics Samsung Medical Center
Dr. Vittal Mogasale IRB Member Head of PER Department IVI
Ms. Deok Ryun Kim IRB Member Research Scientist, Development and Delivery IVI
Prof. Byung-in Choe IRB Member (Non Affiliated) Chair, Division of Institutional Review & Research Ethics Catholic University of Korea
Ms. Yang Hee Kim IRB Member Manager, Clinical operations and Quality Management, Development and Delivery Samsung Bioepis
Prof. Myung Ho Oh IRB Member (Non Affiliated) Professor, Head of Neonatal Intensive Care Unit Soonchunhyang University Chonan Hospital
Prof. Joon Young Song IRB Member (Non Affiliated) Associate Professor, Division of Infectious Disease Korea University Guro Hospital
Dr. Samuel Teshome IRB Member Associate Research Scientist, Development and Delivery IVI
Ms. Sl-Ki Lim IRB Member Researcher, Science IVI
Mr. Seong Ho Moon IRB Coordinator, IRB Member IRB Coordinator IVI
Dr. Viliam Pavliak IRB Member Head, Vaccine Development Department, Science IVI

IRB Meeting Schedule (January 2017 – December 2017)

  • Regular full board meeting will be held on the last Wednesday of every month, where possible.
  • Additional meetings can be held two weeks later but no later than 4 weeks from the date that applications are received, where necessary, with approval of the IRB Chairperson and IRB Expert Secretary.
  • The applications that will need expedited or exempt review can be submitted to the IRB regardless of these dates. The review result will be delivered within 10 working days from the date that applications are received.
Months in 2017 Submission Deadline IRB Meeting Dates
January January 5 January 19
February February 9 February 23
March March 16 March 30
April April 13 April 27
May May 11 May 25
June June 15 June 29
July July 13 July 27
August August 17 August 31
September September 14 September 28
October October 12 October 26
November November 16 November 30
December December 6 December 21

Links to related sites

  1. CIMOS International conference on Revision of the 1993 CIOMOS international ethical guidelines on Biomedical Research Involving human Subjects (2002 Mar)http://www.cioms.ch
  2. Guidance for Good Clinical Practice, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)http://www.ich.org
  3. WHO Operating Guidelines for Ethical Review Committee that Review Biomedical Researchhttp://www.searo.who.int/LinkFiles/RPC_Operational_Guidlines_Ethics.pdf
  4. Declaration of Helsinkihttp://www.wma.net/en/30publications/10policies/b3
  5. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boardshttp://www.who.int/tdr/publications/tdr-research-publications/operational-guidelines/en

Contact Information

IVI IRB Office